Surgical alignment guide assembly for total ankle replacement and method of using the same

ABSTRACT

A surgical guide assembly is disclosed herein that includes instruments configured to aid in the alignment of surgical instruments. In one aspect, a first and second instrument are provided that are configured to be connected to each other via interfaces and each define bone contact interface. The bone contact interfaces are configured to engage with the tibia and talus, in one embodiment.

INCORPORATION BY REFERENCE

This application is a continuation application of U.S. patentapplication Ser. No. 17/363,471, filed on Jun. 30, 2021, the entirecontents of which is incorporated herein by reference as if fully setforth.

FIELD OF INVENTION

The present disclosure relates to tools and methods for performing anklereplacement surgery.

BACKGROUND

Ankle replacement surgery is a procedure for treating patients with endstage ankle arthritis, rheumatoid arthritis and other painfullyarthritic conditions of the ankle or other maladies. Total anklereplacement (TAR), as it is commonly referred to, is typically not asclinically successful as other total joint replacements (i.e. knee, hip,shoulder). The failure rates of TAR procedures are sometimes two orthree times greater than total knee or total hip replacement.

One of the more difficult aspects of a TAR procedure is manuallyaligning the patient's ankle joint so that the surgeon may make theappropriate bone resection cuts. The location and accuracy of the boneresection cuts determine the location of the total ankle implant andultimately determine how well the implant will function and to whatextent the patient's quality of life has improved. Accordingly, makingaccurate incisions is critical to a successful surgery and recovery.

The ankle joint must be appropriately aligned with long axis of thetibial bone in order to place the implant where it will most effectivelyprovide the requisite range of motion and counteract the forcesexperienced in daily activities, such as walking, jogging, standing,etc. There are six degrees of freedom that must be aligned by thesurgeon during the surgery. The alignment of the ankle joint is achievedwith instruments used to prepare the tibial and talar bones inpreparation of implant placement.

It would be desirable to provide instruments and tools that ensuresurgeons and other medical personnel can perform reliable and accuratealignment of a patient's ankle joint prior to and during surgery.

SUMMARY

Surgical guide assemblies, methods, and modular systems are disclosedherein that generally aid with alignment of tools and instruments duringsurgical procedures.

In one aspect, a surgical guide is disclosed. The surgical guideincludes at least one first surgical instrument having at least onefirst bone contact interface configured to mate with at least a portionof a patient's bony anatomy, and at least one first connection interfaceconfigured to mate with at least one connection interface formed ondifferent surgical instruments. At least one second surgical instrumentis also provided. The second surgical instrument includes at least onesecond bone contact interface configured to mate with at least a portionof the patient's bony anatomy, and at least one second connectioninterface configured to mate with the at least one first connectioninterface such that the at least one first surgical instrument and theat least one second surgical instrument are linked to form an assembly.

When both the at least one first surgical instrument and the at leastone second surgical instrument are contacting a patient's bony anatomy,the assembly is oriented in a predetermined manner relative to thepatient's bony anatomy.

A third surgical instrument is also included that has at least one thirdconnection interface configured to mate with the at least one firstconnection interface, at least one guide opening or aperture for guidingat least one fourth surgical instrument, and at least one adjustablemechanism configured to reposition the at least one guide opening oraperture relative to the patient's bony anatomy.

A method of aligning at least one surgical instrument including at leastone guide opening is also provided. The method can include providing atleast one first surgical instrument and at least one second surgicalinstrument. The method includes arranging at least one of the at leastone first surgical instrument and the at least one second surgicalinstrument on a patient's bone. The method also includes linking the atleast one first surgical instrument and the at least one second surgicalinstrument with each other to form an assembly. Next, the methodincludes removing the at least one second surgical instrument from theat least one bone, leaving the at least one first surgical instrument ina desired alignment position relative to the patient. The method alsoincludes aligning at least one third surgical instrument with the atleast one first surgical instrument and with the at least one bone ofthe patient, and linking the at least one third surgical instrument withthe at least one first surgical instrument. The at least one thirdsurgical instrument includes at least one guide opening, and the methodincludes guiding at least one fourth surgical instrument through the atleast one guide opening.

In another embodiment, a surgical guide is provided. The surgical guideincludes at least one first surgical instrument comprising at least onefirst bone contact interface configured to mate with a portion of boneand at least one first connection interface. The surgical guide alsoincludes at least one second surgical instrument comprising at least onesecond bone contact interface configured to mate with a portion a bone,and a second connection interface configured to mate with the at leastone first surgical instrument to form an assembly. The assembly of theat least one first surgical instrument and the at least one secondsurgical instrument is oriented in a predetermined manner relative tothe patient's bony anatomy when both the at least one first surgicalinstrument and the at least one second surgical instrument arecontacting a patient's bony anatomy.

A method of aligning surgical instruments relative to a patient is alsoprovided. The method includes providing a first instrument including afirst bone contact interface and a second bone contact interface, thefirst bone contact interface and the second bone contact interface eachbeing configured to contact a different bone in a patient. The firstsurgical instrument further includes a first connection interfaceconfigured to mechanically link the first instrument with at least twoother instruments. A second instrument is also provided that includes asecond connection interface configured to mate with the first connectioninterface and a third bone contact interface configured to contact thesame bone as the first bone contact interface. At least one thirdinstrument is also provided that defines an aperture or guide openingconfigured to receive a cutting tool. The at least one third instrumentalso includes a third connection interface that is also configured tomate with the first connection interface. The method includes connectingthe first instrument and the second instrument, and arranging the firstinstrument and the second instrument in contact with a patient's bonyanatomy. The method includes removing the second instrument from thefirst instrument such that the first instrument remains engaged with thepatient's bony anatomy. The method then includes attaching the thirdinstrument to the first instrument, and removing the first instrumentfrom the third instrument such that the third instrument remains engagedwith the patient's bony anatomy.

Other embodiments are disclosed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing Summary and the following Detailed Description will bebetter understood when read in conjunction with the appended drawings,which illustrate a preferred embodiment of the invention. In thedrawings:

FIG. 1A is an anterior view of a first and second instrument mated witheach other.

FIG. 1B is a first perspective view of the first instrument.

FIG. 1C is a second perspective view of the first instrument.

FIG. 1D is a third perspective view of the first instrument.

FIG. 1E is a fourth perspective view of the first instrument.

FIG. 1F is a first perspective of the second instrument.

FIG. 1G is a second perspective view of the second instrument.

FIG. 1H is a third perspective view of the second instrument.

FIG. 1I is a fourth perspective view of the second instrument.

FIG. 2 is a perspective view of an embodiment of the first and secondinstruments mated with each other.

FIG. 3 is another perspective isometric view of the first and secondinstruments positioned relative to a patient's anatomy.

FIG. 4 is an anterior view of the first and second instruments inposition relative to a patient's anatomy.

FIG. 5 is a lateral view of the first and second instruments in positionrelative to a patient's anatomy.

FIG. 6A is a perspective view of the first instrument and a thirdinstrument mated with each other.

FIG. 6B is an anterior view of the first instrument and the thirdinstrument from FIG. 6A.

FIG. 6C is another perspective view of the first instrument and thethird instrument from FIG. 6A.

FIG. 7A is a lateral view of the first and third instruments deployedrelative to a patient's anatomy.

FIG. 7B is an anterior view of the first and third instruments deployedrelative to a patient's anatomy.

FIG. 8A is an isometric view of the third instrument connected to afifth instrument.

FIG. 8B is an anterior view of the third instrument connected to thefifth instrument.

FIG. 8C is a perspective view of a third instrument according to oneaspect.

FIG. 9A is a lateral view of the third and fifth instruments connectedto each other and deployed to a patient's anatomy.

FIG. 9B is an anterior view of the third and fifth instruments connectedto each other and deployed to a patient's anatomy.

FIGS. 10A and 10B are perspective views of the third and fifthinstruments deployed to the patient's anatomy as used in connection witha fourth instrument.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In general, total ankle replacement surgery requires that a patient isplaced supine on an operating table support. A protrusion or bump can beplaced under the patient's calf to maintain proper rotation of thepatient's leg. The patient's patella is arranged to face directlyanterior. General or regional anesthesia may be used. If using regionalanesthesia, the sciatic or popliteal catheter must be positioned in away that does not interfere with the surgery. A thigh tourniquet isgenerally used proximal to the popliteal catheter. Intravenousantibiotics and sequential compression are used on the contralateralleg. The leg is prepared and draped using proper sterile technique,leaving the knee to foot exposed. Exsanguination is performed prior totourniquet activation.

A skin incision is made just lateral to the tibial crest fromapproximately 6 cm proximal of the tibial plafond, and extending distalup to the talonavicular joint. The superficial peroneal nerve isidentified and mobilized laterally. The extensor retinaculum andextensor hallucis longus (EHL) tendon sheath are exposed, but theanterior tibial tendon sheath cannot be exposed. The deep peroneal nerveand artery are then identified and mobilized laterally. It is importantto protect these structures throughout the procedure. Finally, the anklejoint capsule is incised longitudinally and exposed from the medialmalleolus to the syndesmosis. Osteophytes on the neck of the talus andanterior tibia must be removed. It is important to avoid weakening theunderlying bone by removing too much substrate. If a varus deformityrequires correction, a deltoid release is performed. It is important torelease the talar deltoid attachment from anterior to posterior as asingle structure. As explained above, these surgeries and procedures arecomplicated and require that surgeons can correctly, accurately, andprecisely have access to specific portions of the patient's anatomy.Accordingly, the subject matter disclosed herein provides an improvedtool, process, and method of aligning surgical instruments and toolsrelative to a patent.

Aspects and embodiments of a surgical guide are disclosed herein thataid surgeons in operating on patients during surgeries, such as totalankle replacement surgeries.

A first surgical instrument 100 and a second surgical instrument 200 aregenerally illustrated in FIGS. 1A-1I. These two instruments 100, 200 aregenerally configured to work in conjunction with each other to aid inthe alignment of tools and instruments relative to a patient's anatomy.

In one embodiment, the first surgical instrument 100 has a first bonecontact interface 101 that is configured to engage with a least aportion of a patient's bones, such as a first bone 300 of a patient. Thefirst bone 300 can be the tibia, or any other bone.

As used herein, the terms surgical instrument, instrument or tool areused interchangeably. Additionally, in one aspect, the term instrumentrefers to a modular tool that primarily is configured to both engagewith other tools or instruments and also is configured to interact witha patient, either via bone contacting surfaces, apertures for receivingguide wires or K-wires, slots configured to receive cutting tools, orother features.

In one aspect, the first bone contact interface 101 is configured tocontact, interface, or mate with a patient's tibia. One skilled in theart would understand that the first bone contact interface 101 can beconfigured to contact, interface, or mate with other bones or patientanatomy. The first bone contact interface 101 generally includes acurved surface, as shown in FIGS. 1D, 1E, and 2 . The specific profileand geometry of the first bone contact interface 101 can be preciselyselected to match a patient's anatomy using imaging techniques. In otherwords, the first bone contact interface 101 can be customized ortailored to match a patient's geometry. In one aspect, this process isbased on a negative mold of a patient's anatomy, which can be based onelectronic imaging data or other techniques.

The first surgical instrument 100 also includes a connection interface102, which is also referred to as a first connection interface. In oneaspect, the connection interface 102 is a surface designed to allow thefirst surgical instrument 100 to mate or connect with additionalsurgical instruments. In one aspect, the connection interface 102 caninclude a slot 102 a including a pair of arms 102 b, 102 c. In oneaspect, the slot 102 a is configured to receive a protrusion. One ofordinary skill in the art would understand that alternatively, theconnection interface 102 can be a protrusion and a slot can be formed onanother instrument to connect with the protrusion. As shown in FIG. 1C,each of the arms 102 b, 102 c extend for an entire edge of a base body110 of the first instrument 100. Other types of connection interfacescan be used.

The first surgical instrument 100 can also comprise a second bonecontact interface 103 configured to mate with a second bone of a patient400, such as the talus. The specific profile and geometry of the secondbone contact interface 103 can be precisely selected to match apatient's anatomy using imaging techniques. In other words, the secondbone contact interface 103 can be customized or tailored to match apatient's geometry. In one aspect, this process is based on a negativemold of a patient's anatomy, which can be based on electronic imagingdata or other techniques.

A joint or interface is defined between the first bone 300 and thesecond bone 400. As shown in FIG. 5 , in one aspect, the first surgicalinstrument 100 is configured to engage a lower region of the first bone300 (i.e. the tibia) via the first bone contact interface 101 and alsocontact an upper portion of the second bone 400 (i.e. the talus) via thesecond bone contact interface 103. In this respect, the first surgicalinstrument 100 can be configured to contact two bone surfaces on twodifferent bones 300, 400.

The second surgical instrument 200 is configured to engage or contact anupper region of the first bone 300 (i.e. the tibia) via its bone contactinterface 201. As shown in FIG. 5 , the first bone contact interface 101of the first surgical instrument 100 and the bone contact interface 201of the second surgical instrument 200 can be configured to contact asame side or face of the first bone 300. In one aspect, the firstsurgical instrument 100 is configured to contact two bones that haveopposing joint surfaces between them. In one aspect, adjustments madeusing the instruments disclosed herein are primarily directed toadjustments relative to the first bone 300.

In one aspect, at least one aperture 104, 104 a, 104 b, 104 c, 104 d,104 e may be provided on the first instrument 100. The apertures 104,104 a, 104 b, 104 c, 104 d, 104 e can each be configured to receive oraccept a stabilizing component, such as k-wire, a drill, a pin, a screw,or other component used to stabilize the first instrument 100 to thefirst bone 300 of the patient or the second bone 400 of the patient. Asshown in FIG. 1E, at least one of the apertures 104 c is defined withinthe first bone contact interface 101. One skilled in the art wouldunderstand that other apertures could also be defined on the first bonecontact interface 101.

In one aspect, an alignment feature 105 may be provided on the firstsurgical instrument 100. The alignment feature 105, which is alsoreferred to as a first alignment feature 105, can be defined on anopposite lateral side 112 of the base body 110 as the first bone contactinterface 101. In one aspect, the alignment feature 105 is configured toaid in the alignment of at least one other instrument. For example, thealignment feature 105 can be used for the alignment with or between atleast one of: the second surgical instrument 200, the first surgicalinstrument 100 relative to the first bone 300, or the first surgicalinstrument 100 relative to one or more of the other bones (such as bones500, 501, 502) of the foot or bones of the leg or other anatomiclocation, such as the knee or femur. The alignment feature 105 can beformed as a slot that extends for an entire face of the base body 110and between two edges of the base body 110. In one aspect, the alignmentfeature 105 overlaps with at least one aperture 104 c.

In one aspect, the first surgical instrument 100 generally has arectangular or square shaped base body 110. The exact shape of the firstsurgical instrument 100 can vary, as would be appreciated by one ofordinary skill in the art based on the present disclosure. The firstbone contact interface 101 protrudes outward from a lateral side 107 ofthe base body 110 in one aspect. The second bone contact interface 103similarly protrudes from the base body 110. The second bone contactinterface 103 protrudes from a bottom surface 109 of the base body 110,in one aspect. The second bone contact interface 103 can protrude fromother sides or surfaces of the base body 110. The connection interface102 can be defined on a top surface 111 of the base body 110, which isopposite from the bottom surface 109 partially defining the second bonecontact interface 103.

The second surgical instrument 200 generally has a square or rectangularbase body 210, in one embodiment. The second surgical instrument 200includes a corresponding mating surface or connection interface 202 thatis configured to mate or connect with the connection interface 102 ofthe first surgical instrument 100. The connection interface 202 is alsoreferred to as a second connection interface herein. As shown in FIG.1A, the second connection interface 202 can include a pair ofprotrusions or protruding flanges 202 a, 202 b dimensioned to be slidunder the arms 102 a, 102 b. One of ordinary skill in the art wouldunderstand that the first surgical instrument 100 could includeprotruding flanges and the second surgical instrument 200 could includea slot configured to receive the protruding flanges. Additionally, othertypes of mating interfaces can be used. In one aspect, the secondconnection interface 202 is formed on a bottom surface 209 of the basebody 210.

Additional details of the second surgical instrument 200 are shown inFIGS. 1F-1I. The second surgical instrument 200 can include a bonecontact interface 201 that is configured to engage a patient's bone oranatomy. The bone contact interface 201 is also referred to as a thirdbone contact interface 201 herein. The bone contact interface 201 can bedefined on a lateral side or surface 207 of the base body 210. In oneaspect, the bone contact interface 201 is configured to contact the samebone that the bone contact interface 101 contacts. The bone contactinterface 201 can have a generic profile that is not specifically shapedto match a specific patient. In another aspect, the bone contactinterface 201 can be specifically custom made for a particular patient'sgeometry, such as via 3-D modeling or digital imaging.

In one aspect, the first instrument 100 includes exactly two bonecontact interfaces 101, 103 and the second instrument 200 includesexactly one bone contact interface 201. One of ordinary skill in the artwould understand that these bone contact interfaces can vary.

The second surgical instrument 200 can include an alignment feature 205that is configured to be used in conjunction with the first alignmentfeature 105. The alignment feature 205 is also referred to as a secondalignment feature 205 herein. In one aspect, the alignment feature 205is defined on a lateral side 212 of the base body 210.

The first and second alignment features 105 and 205 can be used inconjunction with each other, as well as any other alignment reference orcomponent. Visual markings or other indicia can be implemented with thefirst and second alignment features 105, 205. The first and secondalignment features 105, 205 are shown in FIG. 4 relative to bones 500,501, 502 in the patient's foot, as well as the tibia 300 and the talus400. The alignment features 105, 205 generally aid in positioning thefirst and the second instruments 100, 200 relative to each other and/orthe patient's anatomy.

In one aspect, the second surgical instrument 200 lacks any apertures orother openings configured to receive a K-wire or guide wire, and insteadonly includes the third bone contact interface 201, the secondconnection interface 202, and the second alignment feature 205.

In one aspect, both the first and the second instruments 100, 200 can bespecifically formed or designed for an individual patient based onpatient specific data. For example, digital image data may be obtainedusing imaging techniques, such as but not limited to X-rays, CT scans,MRIs, such that any one or more of the first, second, and third bonecontact interfaces 101, 103, 201 replicate the patient's specificanatomy. In another aspect, at least one or both of the first and secondbone contact interfaces 101, 103 on the first instrument 100 includepatient specific profiles, and the third bone contact interface 201 onthe second instrument 200 includes a generic bone contact interface. Inone embodiment, surfaces 101 and 201 are generic and surface 103 isspecifically modeled based on a patient's anatomy.

In one aspect, the bone contact interfaces 101, 103, and 201 arespecifically formed or designed to match or complement the patient'sanatomy. One of skill in the art would understand that other componentsof any of the instruments disclosed herein can be specifically selectedor formed based on a patient's anatomy. Contact between the bone contactinterfaces 101, 103, and 201 and the patient's bones 300, 400 is bestshown in FIG. 5 . As also shown in FIG. 5 , outward surfaces (i.e.surfaces opposite from the bone contact regions) of the first and secondinstruments 100, 200 are aligned with each other once the instruments100, 200 are in position.

A third surgical instrument 600, shown in FIGS. 6A-6C, is also providedherein. The third instrument 600 generally includes a connectioninterface 601 (also referred to herein as a third connection interface601) that is configured to mate, link, or otherwise join the thirdinstrument 600 with another instrument, such as the first instrument100. As shown in FIGS. 6A-6C, the third connection interface 601 caninclude a protrusion configured to be slid into the slot formed by thefirst connection interface 102 of the first instrument 100. Theconnection interface 601 is dimensioned to be received under the arms102 a, 102 b of the first instrument 100. This arrangement ensures thatthe third instrument 600 is secured and fixed in position relative tothe first instrument 100.

The third instrument 600 may also include another connection interface602 (also referred to herein as a fourth connection interface 602) thatis configured to allow the third surgical instrument 600 to mate withanother instrument, such as a fifth surgical instrument 620. In oneaspect, the third connection interface 601 and the fourth connectioninterface 602 can be formed on the same end or region of the thirdinstrument 600. As shown in FIGS. 6A-6C, the fourth connection interface602 can include a pair of apertures 602 a, 602 b configured to engagewith a protrusion formed on another instrument.

Both the second and third instruments 200, 600 can be configured toconnect to the same connection interface in one aspect, which can be thefirst connection interface 102 formed on the first surgical instrument100. In another aspect, the second and third instruments 200, 600 can beconfigured to connect to different interfaces.

In one aspect, the third surgical instrument 600 includes at least oneaperture 603, 603 a, 603 b, 603 c, 603 d, 603 e, 603 f, 603 g configuredto accept another surgical instrument or component (i.e. a fourthsurgical instrument), such as a saw, drill k-wire, or a screw that isconfigured to engage a patient's anatomy or bone, such as bones 300 or400.

The third instrument 600 may also comprise at least one adjustablemechanism 604, 604 a, 604 b, 604 c, 604 d configured to adjust positionsof the apertures 603 a, 603 b, 603 c, 603 d, 603 e, 603 f, 603 grelative to patient anatomy, such as bone 300, bone 400, or both.

The mechanisms 604, 604 a, 604 b, 604 c, 604 d can include a pluralityof mechanisms that include a linkage, knob, adjuster, or other interfacethat can cause locking, or adjusting of a relative angle or position ofan upper portion 600 a of the third surgical instrument 600 to a lowerportion 600 b of the third surgical instrument 600.

In one aspect, the third surgical instrument 600 may generallycorrespond to the adjustment assembly 10, as disclosed in US Patent Pub.No. 2021/0077276, which is incorporated by reference as if fully setforth herein, and is commonly owned by Kinos Medical Inc. Certainfunctional and structural characteristics, as well as other features, ofthe third surgical instrument 600 may be similar to the adjustmentassembly 10 as disclosed in US Patent Pub. No. 2021/0077276 unlessotherwise specified herein. Alternatively, a completely different typeof instrument or tool than disclosed in US Patent Pub. No. 2021/0077276can be used in conjunction with the other instruments disclosed herein.In one aspect, certain features of the third surgical instrument 600 aredifferent from the adjustment assembly 10 as disclosed in US Patent Pub.No. 2021/0077276.

In one aspect, the present disclosure allows for medial-lateraladjustment, which is linear adjustment in the coronal plane (i.e. sameplane as varus-valgus). One skilled in the art would understand thatvarious adjustments may be possible based on the instruments disclosedherein, and the adjustments are not limited to a single plane.

In one aspect, the present disclosure provides the ability to use apatient specific guide or instrument (such as the first instrument 100)to mate with a generic, i.e. not patient specific, instrument (such asthe second instrument 200). The generic instrument may then be adjustedafter the patient specific guide or instrument, i.e. the secondinstrument 200, is removed and the patient specific guide or instrument,i.e. instrument 100, remains attached to the patient to aid withalignment of another instrument, i.e. instrument 600, that is configuredto attach to the patient specific guide or instrument.

In one aspect, the adjustment mechanisms 604, 604 a, 604 b, 604 c, 604 dare configured to adjust translation or rotation in a first plane, andadjust rotation or translation in a second plane that is oriented 90degrees to the first plane. One adjustment mechanism can be configuredto adjust rotation in a plane and another adjustment mechanism can beconfigured to adjust translation in that same plane.

The third instrument 600 can also comprise a bone contact interface 605,i.e. a fourth bone contact interface). As show in FIG. 7A, the fourthbone contact interface 605 can be configured to contact bone 300, whichmay be the tibia. In one aspect, the bone contact interface 605 providesan anchoring configuration or fixed point of reference between at leastone portion of the third instrument 600 and the bone that the thirdinstrument 600 contacts. The bone contact interface 605 can also beconfigured to engage with another bone, such as bone 400. In one aspect,the bone contact interface 605 may be configured to contact anypatient's bone or configured to mate with a specific patient's bone. Thebone contact interface 605 can have a generic bone contacting profile,or may include a bone contacting profile that is specifically formed tomatch a specific patient's anatomy.

The fifth instrument 620, as shown at least in FIGS. 8A and 8B, isgenerally configured to attach to a bottom region of the thirdinstrument 600, in one aspect. The fifth instrument 620 comprises aconnection interface 621, also referred to as a fifth connectioninterface, that is configured to allow the fifth instrument 620 to matewith the fourth connection interface 602 of the third instrument 600.Specifically, the connection interface 621 can be formed as a pair ofprotrusions configured to engage within the pair of apertures 602 a, 602b of the third instrument 600.

The fifth instrument 620 may also comprise at least one guide opening622, which may be formed as a slot, aperture, or other gap, that isconfigured to receive another surgical instrument 630 (i.e. a fourthsurgical instrument), including but not limited to, a saw, drill, burr,wire, or screw. As shown in FIGS. 8A and 8B, the at least one guideopening 622 may include a plurality of slots or openings.

As shown in FIG. 8C, the third instrument 600′ may include the at leastone guide opening 622′ instead of the opening being formed on a separateinstrument, i.e. the fifth instrument 620. Another instrument or toolcan be guided through the opening 622′ formed integrally with the thirdinstrument 600′

In one aspect, the fifth instrument 620 comprises a locking mechanism623 used to securely and rigidly attach the fifth surgical instrument620 to the third surgical instrument 600. Other adjustment assemblies orlocking assemblies can be provided.

A surgeon can use adjustment mechanisms 604, 604 a, 604 b, 604 c, 604 dto specifically adjust a segment of the third surgical instrument 600that contains the rigidly attached fifth surgical instrument 620. Inmoving at least one of the adjustment mechanisms 604, 604 a, 604 b, 604c, 604 d, the surgeon can select the orientation that a fourth surgicalinstrument 630 will engage or intersect at least one of the bones, suchas bones 300, 400, or any other bone. This effectively allows thesurgeon to adjust the location of bone preparation completed on at leastone bone (i.e. bones 300 or 400), such as bone removal, bone sawing,bone drilling, or other operations relative to the original placement ofthe first instrument 100, the second instrument 200, the bone 300,and/or the bone 400.

In one aspect, the fifth instrument 620 is configured to be modular withrespect to the third instrument 600. In other words, the fifthinstrument 620 can be provided in a variety of different sizes andhaving different configurations, each configured or fitting onto thethird instrument 600. In another aspect, the fifth instrument 620 isformed integrally with the third instrument 600. In one aspect, thefifth instrument 620 lacks any bone contact surfaces or interfaces.

As shown in FIGS. 10A and 10B, in one aspect, the fourth instrument 630may include a single instrument or tool, or more than one instrument ortool. In one aspect, the fourth instrument 630 includes at least one ofa saw blade, drill, mill, k-wire, pin, or other surgical component.

In one aspect, the connection or mating interfaces (i.e. elements 102,202, 601, 602, etc.) are all formed as generally rectangularprotrusions, slots, or protrusions that mate with each other. In thismanner, the instruments can easily be slid into mating contact with eachother without requiring any tools or complex assembly steps.Additionally, the instruments are reliably secured to each other due tothe elongated contact surfaces defined between the connection or matinginterfaces, which generally are defined along at least an entire endsurface of the respective instruments.

In one embodiment, a method of aligning at least one surgical instrumentcontaining at least one aperture for guiding another surgical instrumentis disclosed. The method includes placing at least one first instrument100 and at least one second instrument 200 in contact with an at leastone bone of a patient. The method includes connecting the at least onesecond instrument 200 to the at least one first instrument 100. In oneaspect, the first and second instruments 100, 200 can be connected witheach other prior to placement onto the bone. In other aspects, eitherone the first or second instruments 100, 200 can be independentlyattached or placed next to the bone prior to connection with the otherinstruments.

The method includes removing the at least one second instrument 200 fromthe at least one bone of a patient, and leaving the first instrument 100in a desired alignment position relative to the patient. The methodincludes aligning at least one third instrument 600 with the at leastone first instrument 100 and aligned with the at least one bone of thepatient, and the at least one surgical instrument 600 is fixated to theat least one bone of the patient. The method includes guiding the atleast one fourth instrument 630 through at least one aperture on thethird instrument 600.

In another aspect, a method of aligning surgical instruments relative toa patient is provided. The method includes providing any one or more ofthe instruments disclosed herein. The method includes connecting thefirst instrument with the second instrument, and arranging the firstinstrument and the second instrument in contact with a patient's bonyanatomy. The method includes removing the second instrument from thefirst instrument such that the first instrument remains engaged with thepatient's bony anatomy. The method includes attaching the thirdinstrument to the first instrument, and then removing the firstinstrument from the third instrument such that the third instrumentremains engaged with the patient's bony anatomy.

In another aspect, a method of aligning at least one surgical instrumentincluding at least one guide opening includes: (i) linking the at leastone first surgical instrument and the at least one second surgicalinstrument with each other to form an assembly, (ii) arranging theassembly of the at least one first surgical instrument and the at leastone second surgical instrument on a patient's bone, and (iii) removingthe at least one second surgical instrument from the at least one boneof a patient, leaving the at least one first surgical instrument in adesired alignment position relative to the patient.

In one embodiment, a surgical guide assembly or configuration isprovided that only includes the first and second instruments 100, 200.

The disclosed assembly and instruments allow for surgeons to place toolsrelative to a patient without relying on external guiding elements (i.e.K-wires or guide wires), and instead relying on the interfaces definedby the instruments with respect to the bone surfaces.

In one aspect, the disclosed subject matter provides for a set ofmodular instruments or tools that allows a surgeon to quickly and easilyalign specific tools or instruments relative to a patient's anatomy.

One of ordinary skill in the art would understand from this disclosurethat any one or more of the embodiments can be used in connection withany one or more of the steps described herein.

Having thus described the present invention in detail, it is to beappreciated and will be apparent to those skilled in the art that manyphysical changes, only a few of which are exemplified in the detaileddescription of the invention, could be made without altering theinventive concepts and principles embodied therein.

It is also to be appreciated that numerous embodiments incorporatingonly part of the preferred embodiment are possible which do not alter,with respect to those parts, the inventive concepts and principlesembodied therein.

The present embodiment and optional configurations are therefore to beconsidered in all respects as exemplary and/or illustrative and notrestrictive, the scope of the invention being indicated by the appendedclaims rather than by the foregoing description, and all alternateembodiments and changes to this embodiment which come within the meaningand range of equivalency of said claims are therefore to be embracedtherein.

The invention claimed is:
 1. A surgical guide comprising: a firstsurgical instrument comprising: a first bone contact interfaceconfigured to contact a tibia of a patient, and a second bone contactinterface configured to contact a talus of the patient, and a firstconnection interface configured to mate with at least one connectioninterface formed on at least one other different surgical instrument,wherein the first connection interface is at least partially defined onan outer end surface of the first surgical instrument; and at least oneadditional surgical instrument configured to mate with the firstconnection interface, the at least one additional surgical instrumentcomprising at least one aperture for guiding another surgicalinstrument; and at least one adjustable mechanism configured toreposition the at least one aperture relative to the tibia of thepatient, wherein the first surgical instrument is configured to contactthe tibia and talus of the patient such that the first surgicalinstrument is oriented in a predetermined manner.
 2. The surgical guideaccording to claim 1, wherein the at least one adjustable mechanismincludes at least two adjustable mechanisms configured to reposition theat least one aperture.
 3. The surgical guide according to claim 2,wherein the at least two adjustable mechanisms are configured toreposition the at least one aperture in two distinct planes that areoriented 90 degrees relative to each other.
 4. The surgical guideaccording to claim 1, wherein the at least one additional surgicalinstrument includes a second connection interface configured to matewith the first connection interface, wherein the second connectioninterface is also configured to mate with a different connectioninterface formed on a surgical instrument different than the firstsurgical instrument.
 5. The surgical guide according to claim 1, whereinthe first surgical instrument and the at least one additional surgicalinstrument are positionable relative to the patient without any externalguiding elements.
 6. A method of aligning surgical instruments, themethod comprising: providing a first surgical instrument including afirst bone contact interface configured to contact a tibia of a patientand a second bone contact interface configured to contact a talus of thepatient, and a first connection interface configured to mate with aconnection interface formed on a different surgical instrument, whereinthe first connection interface is at least partially defined on an outerend surface of the first surgical instrument; arranging the firstsurgical instrument on the tibia of the patient using the first bonecontact interface; linking the first surgical instrument with at leastone additional surgical instrument via engagement between the firstconnection interface and a second connection interface formed on the atleast one additional surgical instrument to form an assembly; removingthe first surgical instrument; and leaving the at least one additionalsurgical instrument in a desired alignment position relative to apatient, wherein the second connection interface formed on the at leastone additional surgical instrument is configured to engage with aconnection interface formed on another surgical instrument that isdifferent than the first surgical instrument.
 7. A method of aligningsurgical instruments, the method comprising: providing a first surgicalinstrument including a first bone contact interface configured tocontact a tibia of a patient and a second bone contact interfaceconfigured to contact a talus of the patient, and a first connectioninterface configured to mate with a connection interface formed on adifferent surgical instrument, wherein the first connection interface isat least partially defined on an outer end surface of the first surgicalinstrument; arranging the first surgical instrument on the tibia of thepatient using the first bone contact interface; and linking the firstsurgical instrument with at least one additional surgical instrument viaengagement between the first connection interface and a secondconnection interface formed on the at least one additional surgicalinstrument to form an assembly, wherein the at least one additionalsurgical instrument comprises at least one aperture for guiding anothersurgical instrument, and at least one adjustable mechanism configured toreposition the at least one aperture relative to the tibia of thepatient.
 8. The method according to claim 7, wherein the at least oneadjustable mechanism includes at least two adjustable mechanismsconfigured to reposition the at least one aperture.
 9. A method ofaligning surgical instruments relative to a patient, the methodcomprising: providing a first surgical instrument including a first bonecontact interface configured to contact a tibia of a patient, a secondbone contact interface configured to contact a talus of the patient, anda first connection interface configured to mechanically link the firstsurgical instrument with at least one other surgical instrument, whereinthe first connection interface is at least partially defined on an outerend surface of the first surgical instrument; connecting the firstsurgical instrument with at least one additional surgical instrument,and arranging the first surgical instrument and the at least oneadditional surgical instrument in contact with the tibia of the patient;and removing the first surgical instrument from the at least oneadditional surgical instrument while the at least one additionalsurgical instrument remains in contact with the tibia of the patient.10. The method according to claim 9, wherein the at least one additionalsurgical instrument comprises at least one aperture for guiding anothersurgical instrument, and at least one adjustable mechanism configured toreposition the at least one aperture relative to an anatomy of thepatient.
 11. The method according to claim 9, wherein the at least oneadditional surgical instrument comprises another connection interfaceconfigured to mate with both the first connection interface of the firstsurgical instrument and a different connection interface formed on adifferent surgical instrument.